CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
ConditionRecurrent Pericarditis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiol Therapeutics Inc.
About this trial
Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation.
Double-blind treatment will be initiated 10 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years of age or older
treatment with an IL-1 blocker for at least 12 months,
free of pericarditis recurrence for at least 6 months and this recurrence, if present, must have occurred in the setting of an interruption or tapering of an IL-1 blocker; and
treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization.
Disqualifiers
Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); systemic autoimmune disease (e.g., systemic lupus erythematosus)
Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
Estimated glomerular filtration rate (eGFR) < 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
Trial design
Design model
Parallel
Treatments tested in this trial
CardiolRx
DrugThe intervention will be administered orally (via syringe) with food twice daily.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: CardiolRxActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
time to pericarditis recurrence
time to a new episode of recurrent pericarditis\* from the timepoint of stopping the IL-1 blocker to Week 24
Time frame
24 weeksSecondary outcomes
1
Proportions of patients free from a new episode of recurrent pericarditis
Proportions of patients free from a new episode of recurrent pericarditis from the timepoint of stopping the IL-1 blocker to week 24
Time frame
24 weeks2
Percentage of days with no or minimal pain
The percentage of days with no or minimal pain as assessed by an NRS score ≤ 2 from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24)
Time frame
24 weeksOther outcomes
1
the mean pain score
\- the mean pain score using an 11-point NRS at Visit 6 (Week 8) and at Visit 9 (Week 24) (highest pain score recorded during the 7 days prior to Visit 6 and Visit 9)
Time frame
week 8, week 242
the change in CRP
\- the change in CRP from Visit 1 (Day 1) to Visit 6 (Week 8) and Visit 9 (Week 24)
Time frame
week 8, week 24Sponsors and contacts
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Source ClinicalTrials.gov